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Hypophosphatemia Deleteriously Affects Outcome of Septic Shock Patients Admitted to ICU

A

Ayman Anis Metry

Status

Completed

Conditions

Effect of Hypophosphatemia on Septic Patients

Treatments

Diagnostic Test: Phosphorus level

Study type

Observational

Funder types

Other

Identifiers

NCT04455113
ASUH612/18

Details and patient eligibility

About

Patients with severe sepsis/septic shock complicated by hypophosphatemia are at high risk of developing morbidities other than that underlying sepsis and more vulnerable to higher mortality rate. Thus, the current study hypothesized that diagnosis and management of hypophosphatemia may be advantageous for reduction of morbidity and mortality rates of septic patients admitted to ICU

Full description

The current study was started since June 2018 till Jan 2020 after approval of the study protocol by the Local Ethical Committee. The study intended to include all patients admitted to ICU with or developed severe sepsis or septic shock within 24-hr after admission to ICU.

All patients admitted to ICU were eligible to evaluation for demographic and clinical data including hemodynamic data. Disease severity and its impact on body organs were evaluated using acute physiology and chronic health evaluation II score (APACHE II) (20) and SOFA (18) scores. Exclusion criteria included maintenance on immunodepressent therapy for any indication, severe hemorrhagic shock, pregnancy and refusal of nearest relative to sign the written concept for study participation. Children and adulthoods younger than 18 years and patients who were expected to die were also excluded from the study.

Enrollment

317 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • All patients admitted to ICU were eligible to evaluation for demographic and clinical data including hemodynamic data.
  • Disease severity and its impact on body organs were evaluated using acute physiology and chronic health evaluation II score (APACHE II) (20) and SOFA (18) scores.

Exclusion criteria

  • Maintenance on immunodepressent therapy.
  • Severe hemorrhagic shock.
  • Pregnancy
  • Refusal of nearest relative to sign the written concept for study participation.

Trial design

317 participants in 2 patient groups

Normo-phosphatemia
Description:
238 patients included in this group. Phosphorus level \>2.5 mg/dl
Treatment:
Diagnostic Test: Phosphorus level
Hypophosphatemia
Description:
79 patients included in this group. Phosphorus level \<2.5 mg/dl
Treatment:
Diagnostic Test: Phosphorus level

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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